- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00858143
Non Interventional Study For Patients Treated With Somavert® (GPOS)
24 agosto 2009 aggiornato da: Pfizer
German Non Interventional Study For Patients Treated With Somavert®
This open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of Somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Non probability samples
Tipo di studio
Osservativo
Iscrizione (Effettivo)
311
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
18 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Descrizione
Inclusion Criteria:
- Subjects with diagnosed acromegaly who were already being treated with Somavert® or were to start treatment with Somavert® were included in the study.
Exclusion Criteria:
- Subjects treated with an investigational drug for treatment of acromegaly.
- Subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery.
- Women who were pregnant or lactating.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
1
|
Post marketing surveillance study = prospective, non-interventional observation of the use of Somavert®
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Serious Adverse Events (SAE) and Adverse Events (AE)
Lasso di tempo: Baseline up to 5 years
|
Long term safety of Somavert in treatment of patients with acromegaly
|
Baseline up to 5 years
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Change From Baseline Insulin-like Growth Factor I (IGF-I)
Lasso di tempo: Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
|
Change: IGF-I concentration at observation minus IGF-I concentration at baseline (local laboratory, different assay).
|
Baseline, Follow-up 1 (FUP 1) at ~6 months , Follow-up 2 (FUP 2) at ~12 months, Follow-up 3 (FUP 3) at ~ 24 months, Follow-up 4 (FUP 4) at ~ 36 months, Follow-up 5 (FUP 5) at ~ 48 months, Follow-up 6 (FUP 6)at ~60 months
|
IGF-I Values Within Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have IGF-I values within normal range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
IGF-I Values Above Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have IGF-I values above normal range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change From Baseline Hemoglobin A 1c (HbA 1c)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: HbA 1c at observation minus HbA 1c at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
HbA 1c Values Within Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have HbA 1c values within normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
HbA 1c Values Below Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
|
Number of participants who have HbA 1c values below normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5), 60 months (FUP 6)
|
HbA 1c Values Above Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with HbA 1c values above normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change From Baseline Glucose (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: glucose at observation minus glucose at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change From Baseline Glucose <(2 Hour Oral Glucose Tolerance Test (2h oGTT)>
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
|
Change: glucose 2h oGTT at observation minus glucose 2h oGTT at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3)
|
Glucose Values Within Normal Range (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants who have glucose values within normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose Values Below Normal Range (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values below normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose Values Above Normal Range (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values above normal range (fasting).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Within Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values (2h oGTT) within normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose (2 Hour Oral Glucose Tolerance Test (2h oGTT)) Values Above Normal Range
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of participants with glucose values (2h oGTT) above normal range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
IGF-I Absolute Values
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
IGF-I absolute values (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose Values (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose values (fasting)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose Values (2h oGTT)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose values - 2 Hour Oral Glucose Tolerance Test (2h oGTT).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Hemoglobin A 1c (HbA 1c) Values
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute value Hemoglobin A 1c (HbA 1c)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change From Baseline Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: IGF-I concentration at observation minus IGF-I concentration at baseline.
(local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Values Insulin-Like Growth Factor I (IGF-I) in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute values Insulin-Like Growth Factor I (IGF-I) in Patients with Diabetes (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Insulin-Like Growth Factor I (IGF-I) Values Within Normal Range in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Within Normal Range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Insulin-Like Growth Factor I (IGF-I) Values Above Normal Range in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with Insulin-Like Growth Factor I (IGF-I) values Above Normal Range (local laboratory, different assay).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Values for Hemoglobin A 1c (HbA 1c) in Patients with Diabetes
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change From Baseline Hemoglobin A 1c (HbA 1c) in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: HbA 1c at observation minus HbA 1c at baseline.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
HbA 1c Values Within Normal Range in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Within Normal Range.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
HbA 1c Values Below Normal Range in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Below Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
HbA 1c Values Above Normal Range in Diabetic Patients
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients with HbA 1c Values Above Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose Change From Baseline in Diabetic Patients (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change: glucose at observation minus glucose at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose Values in Diabetic Patients (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Absolute Glucose Values in Patients with Diabetes (fasting)
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose Values Within Normal Range in Diabetic Patients (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients (fasting) with Glucose Values Within Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Glucose Values Above Normal Range in Diabetic Patients (Fasting)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Number of Diabetic Patients (fasting) with Glucose Values Above Normal Range
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change in Headache Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Headache symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Excessive Sweating Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Excessive sweating symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Joint Pain Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Joint pain symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Fatigue Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Fatigue symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Soft Tissue Swelling Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Soft tissue swelling symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Numbness or Tingling of Limbs Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
Numbness or tingling of limbs symptom in PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in General Physical Condition Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change: score at observation minus score at baseline.
General physical condition symptom in PASQ: disease-specific questionnaire based on the previous 6 questions which evaluated headache, excessive sweating, joint pain, fatigue, soft tissue swelling and numbness or tingling of limbs.
Scoring 0-10 (0 = worst and 10 = best possible).
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Change in Total PASQ Score Using Patient-assessed Acromegaly Symptom Questionnaire (PASQ)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Total PASQ score: total score calculated as sum of items 1-6; range is 0-48.
Change from baseline calculated as total score at observation minus total score at baseline.
PASQ: disease-specific questionnaire consisting of 6 questions scoring 0-8.
Maximum score indicates severe signs and symptoms, with lower scores reflecting improved quality of life.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4)
|
Mean Change From Baseline for Body Weight
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: body weight at observation minus body weight at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change From Baseline for Diastolic Blood Pressure (BP)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: diastolic blood pressure at observation minus diastolic blood pressure at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change From Baseline for Systolic Blood Pressure (BP)
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change: systolic blood pressure at observation minus systolic blood pressure at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 48 months (FUP 5)
|
Change From Baseline in Ring Size
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Change from baseline: ring size at observation minus ring size at baseline
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the Safety Population
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy.
Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration.
Model included terms for IGF-I, growth hormone, age, weight and gender.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® Needed to Normalize the IGF-I Concentration in the ITT Population
Lasso di tempo: Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Adjusted Mean Dose of Somavert® needed to normalize IGF-I concentration during study while simultaneously adjusting for potential confounding baseline variables measured prior to Somavert® therapy.
Multiple linear regression model used to evaluate dose needed to normalise IGF-I concentration.
Model included terms for IGF-I, growth hormone, age, weight and gender.
|
Baseline, 6 months (follow-up 1-FUP 1), 12 months (FUP 2), 24 months (FUP 3), 36 months (FUP 4), 48 months (FUP 5)
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
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Collegamenti utili
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 gennaio 2004
Completamento primario (Effettivo)
1 gennaio 2008
Completamento dello studio (Effettivo)
1 gennaio 2008
Date di iscrizione allo studio
Primo inviato
6 marzo 2009
Primo inviato che soddisfa i criteri di controllo qualità
6 marzo 2009
Primo Inserito (Stima)
9 marzo 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
2 settembre 2009
Ultimo aggiornamento inviato che soddisfa i criteri QC
24 agosto 2009
Ultimo verificato
1 marzo 2009
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- A6291014
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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